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Advanced Life Sciences Announces 2009 Fourth Quarter and Full Year Financial Results

March 11, 2010

CHICAGO, March 11 /PRNewswire-FirstCall/ — Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2009.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)

The net loss allocable to common shareholders for the three months ended December 31, 2009 was $1.5 million or ($0.02) per share compared to a net loss allocable to common shareholders of $2.8 million or ($0.07) per share for the three months ended December 31, 2008. The net loss allocable to common shareholders for the full year 2009 was $9.3 million or ($0.16) per share compared to a net loss allocable to common shareholders of $23.0 million or ($0.59) per share for 2008. The decrease in the net loss for the full year 2009 is due to decreased costs involved in the clinical activities and regulatory review of the Company’s lead compound Restanza(TM).

The Company used approximately $3.1 million in cash in the fourth quarter of 2009 and ended the year with cash totaling $2.8 million. Cash use for the full year was $12.1 million.

Dr. Michael Flavin, Chairman and Chief Executive Officer of Advanced Life Sciences, commented: “We are excited about the opportunities that lie ahead in 2010 as we pursue a focused strategy to position Restanza, our once-daily, oral antibiotic, for success on two major fronts: community acquired bacterial pneumonia (CABP) and biodefense. We plan to continue to work with the U.S. Food and Drug Administration (FDA) to complete a Special Protocol Assessment (SPA) that will lay the groundwork for initiating registration studies for development of Restanza in CABP. We are also continuing to work with Pfizer, our Asia-Pacific regional partner, on development and commercialization plans. In the area of biodefense, we plan to capitalize on our 2009 achievements, which included generating strong, positive data in four pivotal animal trials and receiving $3.8 million from the Department of Defense to study Restanza further as a potential broad-spectrum medical countermeasure. In 2010, we have an opportunity to secure additional non-dilutive capital through government development contracts which may also position us advantageously for procurement discussions with Department of Defense and Health and Human Services. We are also pursuing additional corporate partnerships as well as advancing additional formulations for hospital and pediatric indications with the goal of capturing the full value of the Restanza franchise.”

Full Year Expense Analysis, 2009 versus 2008:

  • Research and development expense. Total research and development expense decreased $11.2 million to approximately $4.5 million for the year ended December 31, 2009 from approximately $15.7 million for the year ended December 31, 2008. The decrease in R&D expense is related to reduced development costs associated with Restanza.
  • General and administrative expense. General and administrative expense decreased $0.8 million to $6.3 million for the year ended December 31, 2009 from $7.1 million for the year ended December 31, 2008.

Fourth Quarter Expense Analysis, 2009 versus 2008:

  • Research and development expense. Total research and development expense increased $0.4 million to approximately $1.3 million for the three months ended December 31, 2009 from approximately $0.9 million for the three months ended December 31, 2008.
  • General and administrative expense. General and administrative expense decreased $1.0 million to $0.9 million for the three months ended December 31, 2009 from approximately $1.9 million for the three months ended December 31, 2008.

Financial Guidance for 2010

On March 10, 2010, the Company filed a Form S-1 registration statement with the Securities and Exchange Commission (SEC) to provide the Company with the flexibility to meet its financing needs for 2010 initiatives. The Company also terminated its Standby Equity Distribution Agreement (SEDA) with YA Global Investments and has withdrawn the Form S-3 with the SEC that allowed for sales of its common stock through the SEDA.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 9:00 a.m. Eastern Time on Thursday, March 11, 2010 to discuss the Company’s fourth quarter and full year financial results. The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888.713.4217 (domestic) or 617.213.4869 (international). The passcode for the conference call is 69970533. A replay of the conference call will be available until May 11, 2010. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 82887406. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at https://www.theconferencingservice.com/prereg/key.process?key=PKX3JLJW4. Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.

About Community Acquired Bacterial Pneumonia (CABP)

CABP is the sixth most common cause of death in the United States. CABP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6 million cases of CABP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2.0 billion for prescribed antibiotics to treat CABP. CABP is potentially fatal if not treated properly, and the bacteria that cause CABP are developing resistance to current standard of care treatments.

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CABP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.

About Restanza

Restanza is a novel, once-a-day, oral antibiotic that is in late stage development for the treatment of CABP and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza’s demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.

About Advanced Life Sciences

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. The Company’s lead candidate, Restanza, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CABP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.

Forward-Looking Statements

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management’s judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.


    ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
    (A Development Stage Company)                      

                                            December 31,      December 31,
    CONSOLIDATED BALANCE SHEETS                 2009              2008
    ----------------------------------------------------------------------

    ASSETS                                             

    CURRENT ASSETS:
      Cash and cash equivalents              $2,841,801        $1,527,108
      Grant receivable                          530,219            63,444
      Prepaid insurance                         111,761           227,313
      Other prepaid expenses and deposits        88,535           143,808
                                                 ------           -------
        Total current assets                  3,572,316         1,961,673
                                              ---------         ---------

    PROPERTY AND EQUIPMENT:
      Furniture and fixtures                    244,072           244,072
      Laboratory equipment                            -           159,186
      Computer software and equipment           258,786           258,786
      Leasehold improvements                    177,253           505,804
                                                -------           -------
        Total property and equipment-at cost    680,111         1,167,848
      Less accumulated depreciation            (624,158)         (760,329)
                                                -------           -------
        Property and equipment-net               55,953           407,519
                                                 ------           -------
    OTHER ASSETS:
      Commercial launch materials             2,760,936                 -
      Deferred offering and financing costs      13,566           450,861
      Other long-term assets                     25,000                 -
                                                 ------           -------

        Total other assets                    2,799,502           450,861
                                              ---------           -------
    TOTAL ASSETS                             $6,427,771        $2,820,053
                                             ==========        ==========

    LIABILITIES AND STOCKHOLDERS'
     EQUITY (DEFICIT)     

    CURRENT LIABILITIES:
      Accounts payable                        $ 604,334        $1,379,941
      Accrued clinical trial and NDA
        expenses                                      -           458,260
      Accrued payroll                           664,436           506,537
      Other accrued expenses                    661,504           352,466
      Accrued interest payable                   73,194            72,572
      Short-term lease payable                    4,350             8,468
                                                  -----             -----
        Total current liabilities             2,007,818         2,778,244

    Long-term lease payable                           -             4,350
    Long-term grant payable                     500,000           500,000
    Long-term notes payable - related party   2,000,000         2,000,000
    Line of credit                           10,000,000         9,915,000
                                             ----------         ---------
        Total liabilities                    14,507,818        15,197,594
                                             ----------        ----------

    COMMITMENTS AND CONTINGENCIES                      

    STOCKHOLDERS' EQUITY (DEFICIT):
      Common stock, $0.01 par
       value-120,000,000 shares authorized;
       84,925,010 issued and outstanding at
       December 31, 2009; 40,810,932
       shares issued and outstanding at
       December 31, 2008                        849,250           408,109
      Additional paid-in capital            122,621,392       109,601,807
      Deficit accumulated during the
       development stage                   (131,550,689)     (122,387,457)
      Noncontrolling interest in
       subsidiary                                     -                 -
                                              ---------        ----------
        Total equity (deficit)               (8,080,047)      (12,377,541)
                                              ---------        ----------
    TOTAL LIABILITIES AND EQUITY (DEFICIT)   $6,427,771        $2,820,053
                                             ==========        ==========

    ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
    (A Development Stage Company)

    CONSOLIDATED STATEMENTS OF OPERATIONS
    --------------------------------------------------------------------------

                                                                  Period From
                                                                   Inception
                                                                  (January 1,
                Three months ended        Twelve months ended        1999)
                    December 31,              December 31,          Through
                ------------------       --------------------     December 31,
                 2009        2008         2009          2008          2009
                ------      ------       ------        ------        ------
    Revenue:
      Manage-
       ment
       fees         $-           $-           $-            $-     $1,161,180
      Grants  1,057,952     208,824    2,793,191       240,830      4,069,592
      Royalty-
       related
       party         -            -            -             -         45,238
                   ---          ---          ---           ---         ------
        Total
        rev-
        enue 1,057,952      208,824    2,793,191       240,830      5,276,010
             ---------      -------    ---------       -------      ---------

    Expenses:
      Research
       and
       deve-
       lop-
       ment  1,302,221      911,120    4,462,281    15,709,293     95,042,682
      Contracted
       research
        and
        development-
        related
        party        -            -            -             -      7,980,299
      Selling,
       general
       and
       admin-
       istra-
       tive    921,706    1,878,971    6,322,849     7,116,549     33,371,486
               -------    ---------    ---------     ---------     ----------
        Total
        expen-
        ses  2,223,927    2,790,091   10,785,130    22,825,842    136,394,467
             ---------    ---------   ----------    ----------    -----------

    Loss
     from
     opera-
     tions  (1,165,975)  (2,581,267)  (7,991,939)   (22,585,012) (131,118,457)

    Net other
     (income)
     expense:
      Interest
       income   (2,225)     (22,517)     (11,561)     (306,846)    (2,960,423)
      Interest
       expense 262,561      215,407    1,036,762       525,703      4,185,615
      Other
      (income)
       expense,
       net      26,643            -      146,092             -        146,092
      Gain on
       sale
       of
       interest
       in
       Sarawak
       Medichem
       Pharma-
       ceuticals
       joint
       venture       -            -            -             -       (939,052)
                   ---          ---          ---           ---        -------

    Net other
     (income)
     expense   286,979      192,890    1,171,293       218,857        432,232
               -------      -------    ---------       -------        -------

    Net
     loss   (1,452,954)  (2,774,157)  (9,163,232)  (22,803,869)  (131,550,689)
             ---------    ---------    ---------    ----------    -----------
    Less
     net
     loss
     attributable
     to the
     non-
     controlling
     interest in
     subsidiary      -            -            -             -              -
                   ---          ---          ---           ---            ---
    Net
     loss
     attributable
     to
     Advanced
     Life
     Sciences
     Holdings,
     Inc.   (1,452,954)  (2,774,157)  (9,163,232)  (22,803,869)  (131,550,689)
             ---------    ---------    ---------    ----------    -----------
    Less
     accumulated
     preferred
     stock
     dividends
     of subsidiary
     for the
     period     43,750       43,750      175,000       175,000      1,844,792
                ------       ------      -------       -------      ---------
    Net
     loss
     avail-
     able
     to
     common
     share-
     hold-
     ers   $(1,496,704) $(2,817,907) $(9,338,232) $(22,978,869) $(133,395,481)
           ===========  ===========  ===========  ============  =============
    Net
     loss
     per
     share
     avail-
     able
     to
     common
     share-
     holders -
     basic
     and
     diluted    $(0.02)      $(0.07)      $(0.16)       $(0.59)
                ======       ======       ======        ======

    Weighted
     average
     shares
     out-
     standing -
     basic
     and
     dil-
     uted   79,087,262   40,808,378   57,781,126    39,098,943
            ==========   ==========   ==========    ==========

SOURCE Advanced Life Sciences Holdings, Inc.


Source: newswire